Head of Quality - Device & Combination Products

Regulatory Jobs; Cambridge (MA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

12 company paid holidays + 3 personal

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Head of Quality for Device and Combination Products based in Cambridge, MA. This hybrid role leads the global quality strategy across design, development, manufacturing, and lifecycle activities, aligning regulatory requirements with Biogen's quality system to ensure inspection readiness.

You will oversee the Global Quality Device organization, drive continuous improvement, and represent Quality Operations in cross-functional programs, audits, and inspections to support

Qualifications

• Knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR.
• Experience engaging with regulatory authorities and notified bodies.
• Experience in people management (>5 years) and project management.
• Strong understanding of CMO-mediated supply chain activities.

Responsibilities

• Develop and implement quality strategies for device/combination product programs.
• Lead global quality team across design, development, manufacturing and quality operations.
• Lead transfers, deviations, investigations and CAPAs.
• Ensure robust, compliant QMS for end-to-end lifecycle management.
• Participate in Health Authority audits and management reviews.
• Oversee GxP activities and provide quality engineering guidance.
• Lead or support continuous improvement of Device and C&P QMS.
• Represent Quality Operations on cross-functional initiatives.
• Support internal and external audits and regulatory inspections.

Skills

Quality leadership

Regulatory knowledge

Project management

People management

GxP/regulatory audits

Supply chain understanding

Regulatory authorities liaison

Supplier management

Cross-functional leadership

Education

BS in Chemical Engineering

BS in Mechanical Engineering

Job description

Biogen is seeking a Head of Quality for Device and Combination Products based in Cambridge, MA. This hybrid role leads the global quality strategy across design, development, manufacturing, and lifecycle activities, aligning regulatory requirements with Biogen's quality system to ensure inspection readiness.

You will oversee the Global Quality Device organization, drive continuous improvement, and represent Quality Operations in cross-functional programs, audits, and inspections to support